Nasal CongestionNCT04910139
A User Study of the Soniflow System for Nasal Congestion Relief
A study testing Soniflow System in people with Nasal Congestion, run by Third Wave Therapeutics at 1 site in United States.
Trial summary
The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nasal Congestion
- What is being tested?
- Soniflow System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jul 2020to 26 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject is >18 years of age
- Subject has had moderate to severe symptoms of nasal congestion for >3 months (TNSS rating of 2 or 3)
- Subject has signed IRB-approved informed consent form
Who cannot join
- Subject has neurologic comorbidities
- Subject has active dental infection
- Subject is pregnant
- Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator)
- Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months
- Subject has been diagnosed with intracranial hemorrhage within the last 6 months
Show all 10Show fewer
- Subject has open scalp wounds or rashes
- Subject has any history of craniotomy without replacement of a bone flap
- Subject has elevated sensitivity to sound
- Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Otolaryngology Medical Group
San Francisco, California, 94108
About this study
The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.
Read the detailed description
The Soniflow System is a non-invasive device to provide rapid relief of nasal congestion. It consists of a headband with ultrasound transducers (hardware) coupled to a Smartphone application (software).
- Conditions
- Nasal Congestion
- Being tested
- Soniflow System
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soniflow SystemDevice
Also called Soniflow System to provide nasal congestion relief
Treatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App.
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment using acoustic energy Receives: Device: Soniflow System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Nasal Symptom Score
TNSS is a measure of nasal congestion, measured as the sum of four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe). The minimum TNSS value is 0. The maximum TNSS value is 12. Lower TNSS score means a better outcome
Measured: 20 minutes
Secondary outcomes (2)
Visual Analog Scale (VAS) for Headache
Visual Analog Scale (VAS) for Headache, using a scale of 0-10. 0 is the minimum and 10 is maximum on this scale. Lower scores mean a better outcome.
Measured: 20 minutes
Visual Analog Scale (VAS) for Facial Pain
Visual Analog Scale (VAS) for Facial Pain, using a scale of 0-10. 0 is minimum and 10 is the maximum value for this scale. Lower scores mean a better outcome.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2021
- Study start15 Jul 2020
- Primary completion26 Jan 2021
- Study completion26 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Nasal CongestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Wave Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jacob Johnson, MD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04910139
- Sponsor's protocol ID
- CP-001
- Status last verified
- Oct 2023
- First submitted
- 23 May 2021
- Last updated
- 12 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A User Study of the Soniflow System for Nasal Congestion Relief
- ClinicalTrials.gov ID
- NCT04910139
- Acronym / sponsor ID
- CP-001
- Conditions
- Nasal Congestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Third Wave TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 26 Jan 2021 (actual)
- Study completion
- 26 Jan 2021 (actual)
- First posted
- 2 Jun 2021 (actual)
- Results
- Posted 12 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Soniflow System consists of an acoustic vibrational headband paired with a Smartphone App to provide rapid relief of nasal congestion.
Detailed description
The Soniflow System is a non-invasive device to provide rapid relief of nasal congestion. It consists of a headband with ultrasound transducers (hardware) coupled to a Smartphone application (software).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: Soniflow SystemTreatment using acoustic energy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subject is >18 years of age
- Subject has had moderate to severe symptoms of nasal congestion for >3 months (TNSS rating of 2 or 3)
- Subject has signed IRB-approved informed consent form
Key exclusion criteria (10 listed)
- Subject has neurologic comorbidities
- Subject has active dental infection
- Subject is pregnant
- Subject has implanted intracranial electrostimulation device(s) (e.g. cochlear implant, deep brain stimulator)
- Subject has undergone sinonasal or craniomaxillofacial surgery within the lats 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soniflow SystemAlso: Soniflow System to provide nasal congestion reliefTreatment using acoustic vibrational headband worn circumferentially at the level of the forehead paired with a Smartphone App. | Device | Treatment |
Primary outcome
Total Nasal Symptom Score
Time frame: 20 minutes
TNSS is a measure of nasal congestion, measured as the sum of four symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (using a scale of 0=None, 1=Mild, 2=Moderate, or 3=Severe). The minimum TNSS value is 0. The maximum TNSS value is 12. Lower TNSS score means a better outcome
2 secondary outcomes
Visual Analog Scale (VAS) for Headache
Time frame: 20 minutes
Visual Analog Scale (VAS) for Facial Pain
Time frame: 20 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob Johnson, MD principal investigator
Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Soniflow System in people with Nasal Congestion, run by Third Wave Therapeutics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Nasal Symptom Score (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.